EXOGEN

FAQ

BELOW ARE THE MOST COMMONLY ASKED QUESTIONS ABOUT EXOGEN.

FAQ - Physician

What is the EXOGEN Performance Program?

The EXOGEN Performance Program guarantees that radiographic healing progression will be shown in nonunion fractures. If the requirements of the program are met and no healing progression is shown, purchase cost of EXOGEN will be refunded to the buyer.

How can EXOGEN CONNECTS help my patients heal?

EXOGEN CONNECTS is a free smartphone app designed to help patients use their device consistently and as prescribed. The app sends automated treatment reminders and provides helpful healing information to encourage daily use.

Will hospitals and/or insurers cover EXOGEN?

EXOGEN may be covered by the hospital. For some patient, depending on their private or occupational insurance there is the possibility for coverage by their insurance plan.
For more information, contact your local EXOGEN representative or contact Bioventus Customer Care.

Can patients with cardiac pacemakers or other active, implantable devices use EXOGEN?

Active, implantable devices like cardiac pacemakers may be adversely affected by close exposure to the EXOGEN device. Patients or other people in close proximity during treatment should be evaluated by a cardiologist or clinician before using the EXOGEN device.

Does EXOGEN have any contraindications?

EXOGEN has no known contraindications.

Can EXOGEN be used safely with metal fixation of nonunion fractures?

Yes, the actions of EXOGEN to treat nonunion† fractures are non-cavitating and nonthermal.44,45 Testing shows that it produces no untoward effects or migration of fixation.46 It is recommended to not place the transducer on top of fixation material, but to chose a different angle to reach the fracture, as metalwork will block the ultrasound wave.

What do I need to do to prepare my patient for EXOGEN treatments?

The EXOGEN transducer must be in direct contact with skin, so if your patient needs or currently has a cast, you’ll need to build in a transducer port or create a window. Our trained EXOGEN specialists will assist you with proper placement of the transducer port for casting and use with metals for nonunion fractures. For more information, download the EXOGEN Casting Application Techniques; or call Bioventus Customer Care.

What does the EXOGEN unit include?

The EXOGEN unit consists of the main operating unit and the attached cable with transducer head. Patients also receive an application strap, coupling gel and battery charger.

Is EXOGEN able to treat the entire fracture?

Tibia fractures up to 6.35 cm in length were healed in clinical trials using the EXOGEN system.2 The biological effect of the ultrasound beam spreads around the entire fracture by stimulating cells facing the transducer, by penetrating the bone to stimulate cells on the bone’s far side and by transmitting longitudinal and shear waves around the bone.41

Is EXOGEN treatment effective with deep fractures such as in the femur?

In clinical evaluation, EXOGEN had a 92% success rate in treating nonunions of the femur,42 suggesting that EXOGEN is an excellent choice for patients with deep fractures.

How effectively does EXOGEN penetrate soft tissue?

The EXOGEN ultrasound beam expands to reach a width almost 2.5 times the size of the transducer. At its widest, the effective diameter of the ultrasound beam is more than 5 cm, and the therapeutic span is more than 3.4 cm—even after passing through 20 cm of soft tissue.39 EXOGEN ultrasound waves can penetrate through skin and soft tissue to reach bone up to 26.5 cm deep.43

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*Summary of Indications for Use

EXOGEN is indicated for the non-invasive treatment of osseous defects (excluding vertebra and skull) that includes the treatment of delayed unions, nonunions,† stress fractures and joint fusion. EXOGEN is also indicated for the acceleration of fresh fracture heal time, repair following osteotomy, repair in bone transport procedures and repair in distraction osteogenesis procedures.

There are no known contraindications for the EXOGEN device. Safety and effectiveness have not been established for individuals lacking skeletal maturity, pregnant or nursing women, patients with cardiac pacemakers, on fractures due to bone cancer, or on patients with poor blood circulation or clotting problems. Some patients may be sensitive to the ultrasound gel. Full prescribing information can be found in product labeling, at exogen.com, or by calling Bioventus Customer Care at 0800 05 16 384 (UK) / 1800 552 197 (IR).

† A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.

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